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CFT1946

Phase 1

Solid Tumors | Small molecule | Oncology |C4 Therapeutics, Inc.|Last Updated: Nov 21, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment89
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05668585A Study to Characterize the Safety, Tolerability, and Preliminary Efficacy of CFT1946 as Monotherapy and Combination Therapy in Subjects With BRAF V600 Mutant Solid TumorsPHASE1 COMPLETED 89 — — Dec 8, 2022Nov 5, 2025Nov 21, 202526 United States, France +3
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Study Endpoints
Primary Endpoints
Frequency and severity of AEs and SAEs
From enrollment until 30 days after completion of study treatment

Phase 1

Incidence of dose limiting toxicities (DLTs)
From enrollment until 28 days after first dose

Phase 1

Number of subjects with changes between baseline and post-baseline safety assessments based on safety laboratory results graded by CTCAE v5.0
From enrollment until 30 days after completion of study treatment

Phase 1

Frequency of dose interruptions and dose reductions
From enrollment until 30 days after completion of study treatment

Phase 1

Frequency of AEs leading to discontinuation of study treatment(s)
From enrollment until 30 days after completion of study treatment

Phase 1

Overall response rate (ORR)
Up to approximately 43 months

Phase 2 only according to RECIST v1.1 criteria

Disease control rate (DCR) at 3, 6, and 12 months
Up to 12 months

Phase 2

Duration of Response (DOR)
Up to approximately 43 months

Phase 2

Secondary Endpoints
Frequency and severity of AEs and SAEs
From enrollment until 30 days after completion of study treatment
Number of subjects with changes between baseline and post-baseline safety assessments based on safety laboratory results graded by CTCAE v5.0
From enrollment until 30 days after completion of study treatment
Frequency of dose interruptions and dose reductions
From enrollment until 30 days after completion of study treatment
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1: Arm A: CFT1946EXPERIMENTALApproximately 40 subjects with V600 Solid Tumors (non-CNS) (post BRAF inhibitor for NSCLC, CRC, melanoma, ATC)
Phase 1: Arm B: CFT1946 + trametinibEXPERIMENTALApproximately 28 subjects with V600 Solid Tumors (non-CNS) (post BRAF inhibitor for NSCLC, CRC, melanoma)
Phase 2: Arm A1: CFT1946EXPERIMENTALApproximately 30 subjects with V600 melanoma or NSCLC (post BRAF inhibitor)
Phase 2: Arm B1: CFT1946 + trametinibEXPERIMENTALApproximately 20 subjects with V600 melanoma or NSCLC (post BRAF Inhibitor)
Phase 1: Arm C: CFT1946 + cetuximabEXPERIMENTALApproximately 30 subjects with CRC (post BRAF inhibitor)
Phase 2: Arm C1: CFT1946 + cetuximabEXPERIMENTALApproximately 40 subjects with CRC (post BRAF inhibitor)
Interventions
NameTypeDescription
CFT1946DRUGSpecified oral dose on specified day
TrametinibDRUGSpecified oral dose on specified day
CetuximabDRUGSpecified intravenous dose on specified day
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: 1. Subject (or legally authorized representative, where applicable) is willing and able to provide signed informed consent and can follow protocol requirements 2. Subject is ≥18 years of age at time of informed consent 3. Eastern Cooperative Oncology Group performance status of ...

Countries:United StatesFranceGermanySpainUnited Kingdom
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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